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Retrospective Quality Assessment of Lyophilized Rabies Vaccine by Vero Cell for Human Use8 ]0 C2 q; S& G& ^6 A: O
Chunhui He, Haolin Fang, Yebo Li, Ting Zhou, Mingjian Chen, Lefeng Zhang, Qi Zhao, Huiyu Yu, Zihang Xu, Jieping Liu% @ W0 G- O/ T
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* ~; `' U* F: q- iObjective: A retrospective analysis of critical quality attributes was conducted to evaluate product quality and manufacturing process control capability of lyophilized rabies vaccine (Vero cell) for human use during 2014-2018. Methods: Statistical analysis was performed on three critical quality evaluation parameters: potency assay, residual bovine serum albumin content, and moisture content. Quality trends and batch-to-batch consistency were assessed by integrating these results with the company's annual process performance index. Results & Conclusion: All critical parameter test results, including potency, residual bovine serum albumin, and moisture content, conformed to standard specifications. Most results remained within annual mean ±3SD, indicating favorable inter-lot consistency. All process performance index values were ≥1.33, demonstrating adequate process control capability.
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% ]- V1 P0 I5 i7 Y7 u. VKeywords: `$ C. a; h5 f# [/ }
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Rabies, Rabies Vaccine, Quality Analysis
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Full Text:[size=0.85em]PDF2 d+ ]3 ~1 {1 O5 h" j
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DOI: https://doi.org/10.21092/jav.v14i3.121
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